Atlas FDA

1980

2,857 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ASPIRATION TRAY W/FERRIS DISP. ILLINOIS (K800411)A.D.T. Lab Industries1980-04-28
GAS PAK II DIS. GENERATOR ENVELOPES (K800796)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-24
VENOUS M/A INTERNAL JUGULAR KIT (K800620)Norton Performance Plastics Corp.1980-04-24
SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS (K800780)Sandare Chemical Co., Inc.1980-04-24
DIGOCTK 125 (K800773)Sorin Biomedica, Fiat, USA, Inc.1980-04-24
SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET (K800618)Norton Performance Plastics Corp.1980-04-24
AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY (K800820)Calbiochem-Behring Corp.1980-04-24
THERMODILUTION CATHETER INTRO. KIT (K800619)Norton Performance Plastics Corp.1980-04-24
RIONET &/OR RION HEARING AID MODEL HA-82 (K800739)Rion Acoustic Instruments, Inc.1980-04-24
CORN MEAL AGAR MEDIA (K800807)Isle Media and Sterile Products, Inc.1980-04-24
SERALYZER URIC ACID REAGENT STRIPS - (K800848)Miles Laboratories, Inc.1980-04-24
RIONET &/OR RION HEARING AID MOD. HB-67S (K800738)Rion Acoustic Instruments, Inc.1980-04-24
MOD. MCI 17 MANUAL CUFF INFLATOR (K800767)Medasonics, Inc.1980-04-24
Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST (K800769)Sclavo, Inc.1980-04-24
MEDSPEC OPERATIVE OPTHALMIC KIT (K800404)Medi-Spec1980-04-24
GEMENI IGM ASSAY (K800450)Electro-Nucleonics Laboratories, Inc.1980-04-24
FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC. (K800147)Usifroid1980-04-24
STERILE WATER & SALINE IN PLASTIC BTL. (K800753)Travenol Laboratories, S.A.1980-04-24
GEMENI IGG ASSAY (K800451)Electro-Nucleonics Laboratories, Inc.1980-04-24
MEDI-THERM (K800812)Gaymar Industries, Inc.1980-04-24
SERIES 602 CKGTM RECORDER (K800851)Cardio Kinetics, Inc.1980-04-24
CENTRIFICHEM CHOLESTEROL (K800765)Union Carbide Corp.1980-04-24
KMA FLOW DIRECTED THERMODILUTION CATHETE (K800836)Kma, Inc.1980-04-24
CHLAMYDOSPORE AGAR (K800818)Isle Media and Sterile Products, Inc.1980-04-24
MISER INHALATION DEVICE, PART NO. 700 (K800763)Vix Breathing Equipment Co.1980-04-24
PRE-DENT SYSTEM (K800736)Pre-Dent System1980-04-24
PERCUTANEOUS CATHETER INTRODUCER ADAPTER (K800621)Norton Performance Plastics Corp.1980-04-24
ECHO-COMP (K800766)Digisonics, Inc.1980-04-24
JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE (K800623)Pilling Co.1980-04-24
GAMMA STICK CORTISOL RIA KIT/STICK KIT (K800538)Alpha Gamma Laboratory1980-04-24
DIAGNOSTIC PRODUCTS CORP. RIA CONTROL (K800813)Diagnostic Products Corp.1980-04-24
RAPI/TEX ASO STANDARD SERUM (K800642)Calbiochem-Behring Corp.1980-04-24
MODEL 253-11 CYBERLITH PULSE GENERATOR (K800895)Intermedics, Inc.1980-04-24
HUMAN THYROID STIM. HORMONE/ARIA II (K800798)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-24
AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY (K800821)Calbiochem-Behring Corp.1980-04-24
GAMMA STICK GENTAMICIN RIA KIT (K800537)Alpha Gamma Laboratory1980-04-24
URI-DIP (R) (K800626)Pharma-Medica of Scandinavia, Ltd.1980-04-24
I.C.S. MINI & SMALL FRAGMENT SET (K800806)Howmedica Corp.1980-04-21
MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO (K800720)Macomb Chemical Co.1980-04-21
SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT (K800770)Sclavo, Inc.1980-04-21
IL MODEL 1303 PH/BLOOD GAS ANALYZER (K800757)Instrumentation Laboratory CO1980-04-21
PRE-PADDED PLASTER/PARIS BAND/SPLINTS (K800752)Ortho-Care, Inc.1980-04-21
CADWELL 7200 (K800648)Cadwell Laboratories, Inc.1980-04-21
DISPOSABLE PRE-GELLED ELECTROSURGICAL (K800557)Vxtra Corp.1980-04-21
MEDICAL COMPARTMENT KNEE PROSTHESIS (K800640)Dow Corning Wright1980-04-21
TESTOK-125 (K800776)Sorin Biomedica, Fiat, USA, Inc.1980-04-21
EPR-200 PROGRAMMER MODEL 010 (K800376)Biotronik Sales, Inc.1980-04-21
FETAL BOVINE SERUM (K800781)Biolabs, Inc.1980-04-21
PATELLAR COMPONENT FOR LUBINUS PATELLAR (K800800)Waldemar Link GmbH & Co. KG1980-04-21
FELDMAN MINI-SAW, #300000 (K800669)KARL STORZ Endoscopy-America, Inc.1980-04-21
RENCTK (K800774)Sorin Biomedica, Fiat, USA, Inc.1980-04-21
ALDOCTK-125 (K800775)Sorin Biomedica, Fiat, USA, Inc.1980-04-21
STEAROTHERMOHILUS SPORE STRIPS (K800482)Mdt Corp., Inc.1980-04-16
SMAC REPLACEMENT REAGENTS, WETTING AGENT (K800670)Diagnostic Solutions, Inc.1980-04-16
DUNRICH TABLES (K800756)Dunrich, Inc.1980-04-16
NOMOS-01 PULSE GENERATOR (K800375)Biotronik Sales, Inc.1980-04-16
MEDI-TRACE DISPOSABLE DOMES/MONITORING (K800706)Graphic Controls Corp.1980-04-16
CENTRAL VEIN CATHETERIZATION KIT (K800741)Medical Components, Inc.1980-04-16
AMERLEX CORTISOL RIA KIT (K800700)Amersham Corp.1980-04-16
CODE QAS.105 PROLACTIN CONTROL SERA (K800708)Amersham Corp.1980-04-16
MCGAW/EPIC I.V. ADMIN. SET (K800403)American Hospital Supply Corp.1980-04-16
SNYDER HEMOVAC TM VENTED WOUND KIT (K800577)Snyder Laboratories, Inc.1980-04-16
MODEL 100 SPECTRAVIEW (K800655)Edwards Laboratories1980-04-16
MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO (K800705)Graphic Controls Corp.1980-04-16
SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP (K800511)American Convertors Div., American Pharmaseal1980-04-16
SMAC REPLACEMENT REAGENTS-WASH SOLUTIONS (K800671)Diagnostic Solutions, Inc.1980-04-16
B-D STASET, I.V. FLOW CONTROLLER (K800600)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-16
PROLACTIN RIA KIT (K800740)Amersham Corp.1980-04-16
SURGERY DISPLAY SYSTEM (K800488)Kent Barker & Assoc.1980-04-16
SHIELD PERFECT FIT; DURA-FIT, DISPOS. (K800528)American Convertors Div., American Pharmaseal1980-04-16
FERRITIN CONTROLS CODE QAS.104 (K800657)Amersham Corp.1980-04-16
MONITEMP BLOOD PACK TEMP. MONITOR (K800667)Liquid Crystal Products, Inc.1980-04-16
SNYDER HYSTERECTOMY Y TUBE KIT (K800543)Snyder Laboratories, Inc.1980-04-16
AMES LAB MANAGEMENT SYSTEM (K800724)Miles Laboratories, Inc.1980-04-16
USCI BIPOLAR BALLON PACING ELECTRODE (K800298)C.R. Bard, Inc.1980-04-16
STANBIO PROSTATIC ACID PHOSPHATASE TEST (K800693)Stanbio Laboratory1980-04-16
CYBERLITH IMPLANTABLE PULSE GEN. #253-02 (K800644)Intermedics, Inc.1980-04-16
NORSEN DEBRIDER (K800647)Medline Industries, Inc.1980-04-16
PAPARELL TYPE 2, BIOLITE COATED SILI- (K800728)Xomed, Inc.1980-04-16
HEPARIN PUMP #7420 (K800570)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-16
MICROMEDIC AUTOMATIC DILUTER (K800606)Micromedic Systems1980-04-16
Y-TYPE INFUSION SET (2 LEAD) (K800358)Haemonetics Corp.1980-04-16
PERITONE (K800191)Laurie Ann Kaiser, Ph.D.1980-04-16
TOBRAMYCIN RIA KIT (K800743)Antibodies, Inc.1980-04-16
SURGIVAC TM (K800578)Snyder Laboratories, Inc.1980-04-16
RST-SERIES CONTROL (K800658)Gamma Biologicals, Inc.1980-04-16
HEMOSAFE (K800346)Med Lab Systems, Inc.1980-04-16
GOODE T-TUBE, BIOLITE COATED SILICONE/TU (K800727)Xomed, Inc.1980-04-16
BI-LEVEL ASSAYED CARD. DRUG CONT., I,II (K800357)Ortho Diagnostics, Inc.1980-04-16
TOPICAL COOLING DEV. TCD. #27-999 (K800717)Cobe Laboratories, Inc.1980-04-16
T-570 TINNITUS MASKER (K800701)Audiotrone1980-04-10
MULTI-FORMAT SFD MODEL 1720 (K800554)Philips Medical Systems (Cleveland), Inc.1980-04-10
MODEL TRIEX-L HOLLOW FIBER DIALYZER (K800549)Extracorporeal Medical Specialities, Inc.1980-04-10
AMES TDA THEOPHYL-LINE TEST (K800646)Miles Laboratories, Inc.1980-04-10
U-STYLE ADAPTER (K800735)American Midwest1980-04-10
S.K. DIAG. ULTRASND. SMALL PARTS SCAN (K800531)Smithkline Diagnostics, Inc.1980-04-10
PFIZER/AS&E 0450 LOCALIZER (K800501)Pfizer Medical Systems, Inc.1980-04-10
KODAK EKTACHEM CLINICAL CHEM. SLIDES (K800628)Eastman Kodak Company1980-04-10
TENZCARE DUAL-CHANNEL STIMULATOR (K800758)3M Company1980-04-10
LUNDIA PLATE DISP. (K800424)Gambro, Inc.1980-04-10
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